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Regulators hold back ‘golden era’ of innovation in pharmaceutical manufacturing

Regulators hold back ‘golden era’ of innovation in pharmaceutical manufacturing
Part 1 of the 6th Annual Report on the pharmaceutical market discusses manufacturing innovation inertia.

How can pharmaceutical packaging production executives prevent “innovation inertia”? A new report outlines key points in the issue and offers solutions from industry expert Girish Malhotra, who warns that regulators are holding back the pharma industry’s ability to innovate because of long approval times and short patent lives.

Malhotra, president of Epcot Intl., an Ohio-based consultancy firm specialized in manufacturing and technology simplification for pharmaceutical and other industries, explains in the report, “The problem we have presently is that, for manufacturing technology innovations to be successful, pharma companies (brand and generics) need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators—in particular the FDA [Food and Drug Administration]—are still dictating approaches to industry without asking what the commercial justifications are to support them.”

He questions whether recommendations are developed by regulators who don’t have any hands-on experience in the development, design, commercialization and/or operation of pharmaceutical manufacturing facilities.

If the dictating doesn’t stop, Malhotra says valuable process advances might never happen. For example, he believes guidelines for current Good Manufacturing Practices (cGMP) prompt pharmaceutical companies to focus on adhering to regulations rather than on innovating.

Malhotra recommends that two paths—shortening the regulatory approval times and working closely with contract services worldwide—will usher in a new golden era of innovation and drug affordability for pharmaceutical companies producing patented products. He also thinks drug shortages will decrease and companies will realize maximum profits, without compromising product quality and safety, if industry takes these two actions.

“Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation. But my fear is that we are still at least three years away from this,” concludes Malhotra.

Malhotra’s insights are highlighted in the first part of the 6th Annual Report by UBM (part of Informa plc), the producer of CPhI Worldwide (Oct. 9-11; Madrid), the world’s largest pharmaceutical event. A full program of sessions brings in experts to analyze how industry can explore new pharmaceutical packaging and manufacturing processes. [Editor’s discloser: UBM owns Packaging Digest.]

On Oct. 9, the entire 6th Annual Report will be released at CPhI, with insights from more than 10 pharmaceutical industry experts.


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